Trial Outcomes & Findings for Effect of tACS Stimulation on Alpha Oscillations (NCT NCT03178344)
NCT ID: NCT03178344
Last Updated: 2019-02-26
Results Overview
Change after stimulation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Before and after 40-minute stimulation at each session.
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Sham Stimulation, Then Alpha Stimulation
Participants will receive sham stimulation at the first session. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham. Then, participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation, Then Sham Stimulation
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes at the first session. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Then, participants will receive sham stimulation at the second session. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
First Session
STARTED
|
10
|
10
|
|
First Session
COMPLETED
|
10
|
10
|
|
First Session
NOT COMPLETED
|
0
|
0
|
|
Washout Period (5-9 Days)
STARTED
|
10
|
10
|
|
Washout Period (5-9 Days)
COMPLETED
|
10
|
10
|
|
Washout Period (5-9 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Session
STARTED
|
10
|
10
|
|
Second Session
COMPLETED
|
10
|
10
|
|
Second Session
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of tACS Stimulation on Alpha Oscillations
Baseline characteristics by cohort
| Measure |
Overall Group (Both Sham and Alpha Stimulation)
n=20 Participants
Participants received sham stimulation at one session and alpha stimulation at the other in a randomized order. Sessions were separated by 5-9 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after 40-minute stimulation at each session.Change after stimulation
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation
n=20 Participants
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
Salivary Alpha Amylase
|
0.00695 log-normalized percent change of U/mL
Standard Deviation 0.196
|
0.03055 log-normalized percent change of U/mL
Standard Deviation 0.188
|
PRIMARY outcome
Timeframe: Before and after 40 minutes of stimulationChange before and after stimulation
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation
n=20 Participants
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
Salivary Cortisol
|
-0.0551 log-normalized percent change µg/dL
Standard Deviation 0.168
|
-0.0702 log-normalized percent change µg/dL
Standard Deviation 0.164
|
SECONDARY outcome
Timeframe: Before and after 40-minute stimulation at each session.Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt\^2, the ratio does not have a unit of measure.
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation
n=20 Participants
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
Heart Rate Variability
|
1.599 log-normalized percent change
Standard Deviation 3.33
|
0.308 log-normalized percent change
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Before and after 40-minute stimulation at each session.Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation
n=20 Participants
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
Percent Change in Respiration
|
-0.0075 Percent change in breaths per second
Standard Deviation 0.076
|
0.0325 Percent change in breaths per second
Standard Deviation 0.093
|
SECONDARY outcome
Timeframe: Before and after 40-minute stimulation at each session.The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
|
Alpha Stimulation
n=20 Participants
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
|
|---|---|---|
|
Electroencephalogram (EEG)
|
-0.0087 percent change of uV^2/Hz
Standard Deviation 0.0360
|
0.0114 percent change of uV^2/Hz
Standard Deviation 0.0752
|
Adverse Events
Alpha Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place